Condition category
Digestive System
Date applied
07/12/2008
Date assigned
08/01/2009
Last edited
03/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
An inguinal hernia is a bulge in the groin, because of a weakness in the underlying muscle. A mesh (or ‘patch’) is placed over the area of weakness, deep to the skin. This strengthens the area and prevents the hernia recurring after the operation. The mesh that we currently use needs to be stitched to the underlying muscle. This is because the hernia would return if the mesh became displaced. However, some researchers believe that the stitches used to fix the mesh may be responsible for some of the pain experienced after the operation. It is normal to have some soreness immediately after the operation, and the pain-killers that we prescribe should keep it under control. However, some people seem to experience more pain than others. Also, some people may develop a condition called ‘chronic groin pain’ after the operation. When this happens, the pain can last for weeks, and sometimes months. In other patients, there may be a persistent numbness in the groin. The new mesh does not need stitching, because it is designed to stick firmly to underlying tissues. Previous research has shown that this mesh is safe and effective. This research aims to find out if this mesh can reduce the incidence and severity of groin pain and numbness, and if it is as effective in repairing the hernia as the traditional mesh. The main aim is to investigate if the ‘suture-less’ or ‘self-gripping’ mesh produces chronic groin pain less frequently than the currently used mesh. Other aims are to study:
If the severity of pain immediately after the operation is reduced
If the incidence of groin numbness is reduced, and
If there is any difference in the recurrence rate of hernias.

Who can participate?
Patients over 16 years of age, who are due to undergo an open repair of an inguinal hernia.

What does the study involve?
Individual participants are randomly assigned to two groups: one group receives the sutured mesh, and the other receives the new mesh. You will not know which mesh you received until the end of the trial.
The entire process (pre-admission checks, admission to day ward, and discharge from hospital) will be the same whether you are participating in this study or not. However, if you are a participant, you will be given a questionnaire to complete, 4 – 6 hours after your operation. This questionnaire is called a McGill Pain Questionnaire. You will probably be discharged from hospital on the same day, but some patients need to remain in hospital overnight for a variety of reasons. Your participation in this study will not influence the decision of whether you get to go home or remain in hospital overnight. Three months after your operation, you will be reviewed in the out-patient’s clinic. If you still experience any pain or numbness, you will be asked to fill in another pain questionnaire. One year after the operation, you will receive a telephone call from a member of the research team. The researcher will ask you a set of standard questions relating to the presence of pain, numbness, and swelling or lump in the groin. If you report that you do have pain, numbness, swelling or a lump, you will be invited to come to outpatient’s clinic for a check-up. We will check to see if your hernia has come back. If you still have pain, we will ask you to complete another pain questionnaire.

What are the possible benefits and risks of participating?
Though your participation may help in deciding if the new mesh is a significant advance in the treatment of hernias, there is unlikely to be any direct benefit to you. Also, though previous studies suggest that the new mesh causes less pain and numbness, these studies have been small and not as detailed as this study. Studies have already proved that the new mesh is safe and effective. However, we do not know if the new mesh is as reliable as the traditional one, in preventing a hernia returning. It is important to remember that you can get a recurrence even with the traditional mesh. This happens in approximately 2% (2 out of every 100) of operations performed.

Where is the study run from?
James Paget University Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
The study started in January 2009 and will end in December 2012

Who is funding the study?
James Paget University Hospital NHS Foundation Trust, Department of Surgery (UK)

Who is the main contact?
Dr Vivek Chitre
vivek.chitre@jpaget.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vivek Chitre

ORCID ID

Contact details

James Paget University Hospital NHS Foundation Trust
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
+44 (0)1493 453658
vivek.chitre@jpaget.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled single-blinded study of sutureless mesh repair of inguinal hernias

Acronym

Study hypothesis

Does the use of a sutureless, self-adhesive mesh in the repair of inguinal hernia result in reduced postoperative pain and chronic pain? Does the use of such a mesh increase the risk of hernia recurrence?

Ethics approval

The study was submitted for an ethical review via NIHR Coordinated System on 07/12/2008, ref: 14211/17530/20/683

Study design

Randomised controlled single-blind single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Open repair of inguinal hernia

Intervention

This is a randomised controlled single-blind (patients) trial.

For the study group, a Progrip™ mesh will be used. This is a lightweight mesh that does not have to be sutured in place, because its design incorporated microscopic 'hooks', which cause the mesh to adhere to tissues. The control group will receive an Ultrapro™ mesh. This is the currently used mesh, and is also a lightweight mesh. The only difference is that it needs to be secured in place by non-absorbable sutures.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 12/12/2012:
Pain, measured using the SF McGill Pain Questionnaire 4-6 hours and 3 months after surgery

Previous primary outcome measures until 12/12/2012:
Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) 4-6 hours after surgery, at 6 weeks and 1 year.

Secondary outcome measures

1. Chronic groin numbness, as reported at 6 weeks and 1 year after surgery
2. Recurrence of hernia, as determined by telephone enquiry of all participants at 6 weeks and 1 year after surgery, and confirmed by physical examination of those reporting either 'lump' or 'swelling'
3. Operating time: as recorded from 'knife-to-skin' to completion of skin closure

Overall trial start date

01/01/2009

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All adult (both males and females, >16 years) patients who are to undergo conventional (open) repair of primary inguinal hernias. In general, all patients who are suitable for a conventional mesh repair are eligible for this trial.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Refusal of consent (these patients will receive the standard sutured mesh repair)
2. Recurrent hernia and bilateral hernia

Recruitment start date

01/01/2009

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

James Paget University Hospital NHS Foundation Trust
Great Yarmouth
NR31 6LA
United Kingdom

Sponsor information

Organisation

James Paget University Hospital NHS Foundation Trust (UK)

Sponsor details

Lowestoft Road
Gorleston
Great Yarmouth
NR14 8GE
United Kingdom
+44 (0)1493 452452
ann.filby@jpaget.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.jpaget.co.uk

Funders

Funder type

Hospital/treatment centre

Funder name

James Paget University Hospital NHS Foundation Trust, Department of Surgery (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/05/2016: No publications found, verifying study status with principal investigator. 12/12/2012: the overall trial end date was changed from 31/12/2009 to 31/12/2012.